Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the PreCheck topic
No spam. Unsubscribe anytime.
FDA highlights PreCheck program to fast-track new U.S. drug manufacturing sites
Summary
At a public generic drug forum, an FDA presenter said the PreCheck program launched Feb. 1 to fast-track new domestic manufacturing facilities, with an initial application deadline of March 1 and planned engagement with selected participants beginning July 1.
An agency official and presenter for the Food and Drug Administration outlined the PreCheck program as a new effort to accelerate establishment of domestic manufacturing capacity. "The PreCheck program officially launched on February 1," the presenter said, and the initial application submission deadline was March 1; FDA plans to begin engaging with selected participants on July 1.
The presenter described PreCheck as a proactive, front-end engagement model that works with manufacturers during design and before facilities become operational. He said the program is intended to strengthen the U.S. pharmaceutical supply chain by helping ensure facilities are built correctly from the start rather than relying solely on inspections after construction.
